Jun 2025 – Present · 11 mos · On-site

• Providing functional expertise and oversight of processes to ensure quality deliverables
• Participating in client meetings and internal team collaborations
• Supporting operations during unplanned peaks or urgent requirements
• Preparing for and responding to internal/external audits and inspections
• Taking appropriate action based on client feedback for performance or process-related concerns
• Providing project updates to management on a periodic basis
• Maintaining up-to-date knowledge of relevant regulations and SOPs

Jan 2024 – May 2025 · 1 yr 4 mos · On-site

• Responsible for Generation, quality control and approval of metrics related to PV compliance as well as other key OCMS compliance metrics.
• Oversight of investigations of Late Health Authority ICSR submissions and Aggregate Report submissions to Health Authorities, monitoring the timely exchange of ICSRs with Alliance partners and monitoring inbound ICSR performance from multiple sources.
• Expertise in investigations and trending of Late Health Authority ICSR submissions and the timely exchange of ICSRs with Alliance Partners.
• Expertise in developing and updating controlled documents.
• Perform User Acceptance Testing for systems used to monitor compliance.

Jul 2020 – Dec 2023 · 3 yrs 5 mos · On-site

• Provided technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
• Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, and other study reports, as well as Medical and Product Dictionary Management activities, where applicable.
• Responsible for ICSR compliance and related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable.
• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
• Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
• Conduct/Attend internal, drug safety and project specific training sessions
• Imparts trainings to the new starts in induction sessions and the team as required.
• Preparation for, participation in, and follow up on audits and inspections
• Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
• Assist in development of project specific safety procedures, workflows and templates as required.
• Delegate work as appropriate to Drug Safety Assistants, Drug Safety Associates, Drug Safety Specialists
• Helps in management of process related queries at user level.
• Active participation in process improvement related activities.
• Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work.

Nov 2018 – Jun 2020 · 1 yr 7 mos · On-site

• Subject Matter expert of Duplicate case processing in safety database.
• Conducted various trainings for handling duplicate cases in database across teams.
• Performing quality checks of ICSRs to ensure high quality of the safety reports in accordance with the client SOPs and regulatory requirements.
• Performing Quality Control (QC) of cases for the accuracy of data captured on the client's database per relevant guidelines and procedures.
• Monitoring the compliance by monitoring the standardized ICSR lateness reasons and associated
• Corrective and Preventive Action (CAPA) plans, as applicable
• Handling ad-hoc requests from Client regarding compliance investigations, as applicable
• Trending of errors identified during lateness reasons observed during compliance monitoring, as applicable.
• Liaising with the client's quality counterparts for data analysis and process improvement, as required.
• Ensuring compliance of client ICSRs with company and regulatory requirements
• Maintaining quality metrics per client requirements, as applicable
• Highlighting any issues emerging from the QC results to the Project Manager/Senior Management
• Maintaining a good working knowledge of the data capture conventions and guidelines and client procedures

Aug 2015 – Oct 2018 · 3 yrs 2 mos · On-site

• Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies.
• Responding to clients/customers in a timely manner
• Requesting additional information as needed from the appropriate sender (affiliate sites, licensee partner, investigators, etc.), as required.
• Identifying areas of concern within the team and raises the issues with the Team Lead.
• Performing quality checks of ICSRs to ensure high quality of the safety reports in accordance with the client SOPs and regulatory requirements.
• Performing Quality Control (QC) of cases for the accuracy of data captured on the client's database per relevant guidelines and procedures.